Segluromet 2.5-500mg Tablets
WARNING: Rarely, metformin may cause too much lactic acid in the blood (lactic acidosis). The risk is higher in people who have kidney problems, liver problems, heart failure, use alcohol, or take certain other drugs, including topiramate. The risk is also higher in people who are 65 or older and in people who are having surgery, an exam or test with contrast, or other procedures. If lactic acidosis happens, it can lead to other health problems and can be deadly. Kidney tests may be done while taking this drug.Do not take this drug if you have a very bad infection, low oxygen, or a lot of fluid loss (dehydration).Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like confusion; fast breathing; fast or slow heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; feeling very tired or weak; very bad dizziness; feeling cold; or muscle pain or cramps. @ COMMON USES: It is used to help control blood sugar in people with type 2 diabetes.
Drug Class
Antidiabetic, Oral
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor; Biguanide
Pregnancy Category
Not available
FDA Approved
Dec 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Segluromet is a combination medicine used to treat type 2 diabetes. It contains two active ingredients: ertugliflozin and metformin. Ertugliflozin works by helping your kidneys remove more sugar from your body through your urine. Metformin works by reducing the amount of sugar your liver makes and helps your body use insulin more effectively. Together, they help lower your blood sugar levels.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with meals as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with meals as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
It's also important to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a healthy diet plan as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Maintain good hydration to prevent dehydration, especially when taking ertugliflozin.
- Limit or avoid alcohol consumption, as it can increase the risk of lactic acidosis with metformin.
- Practice good hygiene to reduce the risk of genital and urinary tract infections.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: Ertugliflozin 2.5 mg / Metformin 500 mg orally twice daily. Titrate based on efficacy and tolerability. Max: Ertugliflozin 7.5 mg / Metformin 1000 mg orally twice daily (total Ertugliflozin 15 mg / Metformin 2000 mg daily).
Dose Range:
2.5 - 15 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Initial: Ertugliflozin 2.5 mg / Metformin 500 mg orally twice daily. May increase to Ertugliflozin 7.5 mg / Metformin 1000 mg orally twice daily if additional glycemic control is needed and tolerated. Take with meals to reduce gastrointestinal side effects of metformin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
eGFR 60 to <90 mL/min/1.73m²: No dose adjustment needed. Continue to monitor renal function.
Moderate:
eGFR 45 to <60 mL/min/1.73m²: Do not initiate Segluromet. If already on Segluromet, discontinue if eGFR persistently falls below 45 mL/min/1.73m².
eGFR 30 to <45 mL/min/1.73m²: Contraindicated to initiate. If already on Segluromet, discontinue.
Severe:
eGFR <30 mL/min/1.73m²: Contraindicated.
Dialysis:
Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed for Ertugliflozin. Metformin should be used with caution.
Moderate:
No dose adjustment needed for Ertugliflozin. Metformin should be used with caution; monitor for lactic acidosis.
Severe:
Not recommended due to increased risk of lactic acidosis with metformin.
Pharmacology
Mechanism of Action
Segluromet is a combination of ertugliflozin and metformin. Ertugliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion and lowering blood glucose concentrations. Metformin is a biguanide that decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. It does not produce hypoglycemia in patients with type 2 diabetes mellitus.
Pharmacokinetics
Absorption:
Bioavailability:
Ertugliflozin: ~60% (oral); Metformin: 50-60% (oral)
Tmax:
Ertugliflozin: 1 hour; Metformin: 2-3 hours
FoodEffect:
Ertugliflozin: No clinically meaningful effect; Metformin: Decreases Cmax by 40% and AUC by 25%, prolongs Tmax by 35 minutes, but clinical significance is minimal, and it is recommended to take with food to reduce GI side effects.
Distribution:
Vd:
Ertugliflozin: ~85.5 L; Metformin: 654 ± 358 L
ProteinBinding:
Ertugliflozin: ~93.1%; Metformin: Negligible
CnssPenetration:
Ertugliflozin: Limited; Metformin: Limited
Elimination:
HalfLife:
Ertugliflozin: ~17 hours; Metformin: Plasma elimination half-life is ~6.2 hours, blood half-life is ~17.6 hours
Clearance:
Ertugliflozin: ~11.1 L/hr; Metformin: Renal clearance is ~3.5 times greater than creatinine clearance, indicating tubular secretion.
ExcretionRoute:
Ertugliflozin: Feces (40.9% as unchanged drug, 50.2% as metabolites), Urine (1.5% as unchanged drug, 34.7% as metabolites); Metformin: Urine (primarily unchanged drug)
Unchanged:
Ertugliflozin: ~1.5% (urine), ~40.9% (feces); Metformin: ~90% (urine)
Pharmacodynamics
OnsetOfAction:
Ertugliflozin: Within hours; Metformin: Within days
PeakEffect:
Ertugliflozin: 1-2 hours (glucose lowering); Metformin: 2-3 hours (plasma concentration), full glucose lowering effect may take 1-2 weeks.
DurationOfAction:
Ertugliflozin: 24 hours; Metformin: 12-24 hours
Safety & Warnings
BLACK BOX WARNING
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal distress. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate/pyruvate ratio; metformin plasma levels were generally >5 mcg/mL. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. If metformin-associated lactic acidosis is suspected, discontinue Segluromet and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Kidney Problems: Difficulty urinating, changes in urine output, blood in the urine, or sudden weight gain.
Vaginal Yeast Infection: Itching, unpleasant odor, or discharge. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or certain fruit juices.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations. To minimize this risk, it is essential to properly care for your feet. Inform your doctor if you have a history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. Seek medical attention immediately if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.
Rare but Serious Infection: A potentially life-threatening infection can occur with this type of medication. Seek medical help immediately if you experience tenderness, redness, or swelling in the genital area or the area between your genitals and rectum, accompanied by fever or feeling unwell.
Stomach Problems: Although common when starting this medication, stomach problems like upset stomach, vomiting, or diarrhea can be a sign of a more serious condition (lactic acidosis) if they occur later during treatment. Contact your doctor immediately if you experience stomach problems.
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following:
Diarrhea, upset stomach, or vomiting
Gas
Headache
Stomach pain or heartburn
* Feeling tired or weak
If any of these side effects or other symptoms bother you or persist, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Kidney Problems: Difficulty urinating, changes in urine output, blood in the urine, or sudden weight gain.
Vaginal Yeast Infection: Itching, unpleasant odor, or discharge. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or certain fruit juices.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations. To minimize this risk, it is essential to properly care for your feet. Inform your doctor if you have a history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. Seek medical attention immediately if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.
Rare but Serious Infection: A potentially life-threatening infection can occur with this type of medication. Seek medical help immediately if you experience tenderness, redness, or swelling in the genital area or the area between your genitals and rectum, accompanied by fever or feeling unwell.
Stomach Problems: Although common when starting this medication, stomach problems like upset stomach, vomiting, or diarrhea can be a sign of a more serious condition (lactic acidosis) if they occur later during treatment. Contact your doctor immediately if you experience stomach problems.
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following:
Diarrhea, upset stomach, or vomiting
Gas
Headache
Stomach pain or heartburn
* Feeling tired or weak
If any of these side effects or other symptoms bother you or persist, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of lactic acidosis: unusual muscle pain, trouble breathing, unusual sleepiness, stomach pain, dizziness, lightheadedness, or a slow/irregular heartbeat. Seek immediate medical attention.
- Signs of dehydration: dizziness, lightheadedness, feeling faint, especially when standing up.
- Signs of urinary tract infection: burning sensation when urinating, frequent urination, urgency, pain in the lower abdomen.
- Signs of genital yeast infection: itching, redness, swelling, or discharge in the genital area.
- Signs of diabetic ketoacidosis (rare but serious): nausea, vomiting, stomach pain, excessive thirst, rapid deep breathing, unusual sleepiness, or a fruity smell to your breath. Seek immediate medical attention.
- Signs of low blood sugar (hypoglycemia): sweating, trembling, dizziness, confusion, hunger, rapid heartbeat (more likely if also taking insulin or a sulfonylurea).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended for its treatment.
The presence of an acidic blood condition.
Kidney disease or being on dialysis.
Liver disease.
A recent heart attack or stroke.
Any difficulties with eating or drinking normally, including situations before procedures or surgery.
If you are scheduled for an exam or test involving contrast or have had one within the last 48 hours, consult your doctor.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is crucial to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended for its treatment.
The presence of an acidic blood condition.
Kidney disease or being on dialysis.
Liver disease.
A recent heart attack or stroke.
Any difficulties with eating or drinking normally, including situations before procedures or surgery.
If you are scheduled for an exam or test involving contrast or have had one within the last 48 hours, consult your doctor.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may need to stop this medication before certain surgical procedures, and will advise you on when to resume taking it after the surgery or procedure.
Monitoring and Testing
Regularly check your blood work and other lab tests as directed by your doctor. Additionally, monitor your blood sugar levels as instructed by your doctor, and discuss with your doctor which glucose tests are most suitable for you.
Safety Precautions
Do not drive if your blood sugar levels are low, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe management of your condition.
Interactions with Lab Tests
This medication may affect certain lab tests, so it is crucial to inform all your healthcare providers and lab workers that you are taking this medication.
Managing Blood Sugar
Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control. Changes in physical activity, exercise, or diet can also impact blood sugar levels.
Dehydration and Fluid Management
If you are unable to drink liquids or experience persistent stomach upset, vomiting, or diarrhea, contact your doctor to prevent dehydration. Dehydration can lead to low blood pressure or worsen kidney problems.
Alcohol Consumption
Consult with your doctor before consuming alcohol while taking this medication.
Heat and Fluid Loss
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent fluid loss.
Potential Side Effects
High cholesterol has been reported with this medication. If you have concerns, discuss them with your doctor.
Long-term Treatment
Prolonged treatment with metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, inform your doctor.
Ketoacidosis
This medication can increase the risk of ketoacidosis, a potentially life-threatening condition. This risk is higher in people with diabetes, pancreas problems, or those who are sick, dehydrated, or skipping meals. Check your ketone levels as directed by your doctor, and seek medical attention if you have questions or concerns.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections and kidney problems have been reported with this medication, and may require hospitalization or dialysis.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Birth Control
Women of childbearing age who have not been ovulating may be at risk of pregnancy while taking this medication. If you wish to avoid pregnancy, use birth control while taking this medication. If you become pregnant or suspect you may be pregnant, contact your doctor immediately, as this medication may harm the unborn baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may need to stop this medication before certain surgical procedures, and will advise you on when to resume taking it after the surgery or procedure.
Monitoring and Testing
Regularly check your blood work and other lab tests as directed by your doctor. Additionally, monitor your blood sugar levels as instructed by your doctor, and discuss with your doctor which glucose tests are most suitable for you.
Safety Precautions
Do not drive if your blood sugar levels are low, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe management of your condition.
Interactions with Lab Tests
This medication may affect certain lab tests, so it is crucial to inform all your healthcare providers and lab workers that you are taking this medication.
Managing Blood Sugar
Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control. Changes in physical activity, exercise, or diet can also impact blood sugar levels.
Dehydration and Fluid Management
If you are unable to drink liquids or experience persistent stomach upset, vomiting, or diarrhea, contact your doctor to prevent dehydration. Dehydration can lead to low blood pressure or worsen kidney problems.
Alcohol Consumption
Consult with your doctor before consuming alcohol while taking this medication.
Heat and Fluid Loss
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent fluid loss.
Potential Side Effects
High cholesterol has been reported with this medication. If you have concerns, discuss them with your doctor.
Long-term Treatment
Prolonged treatment with metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, inform your doctor.
Ketoacidosis
This medication can increase the risk of ketoacidosis, a potentially life-threatening condition. This risk is higher in people with diabetes, pancreas problems, or those who are sick, dehydrated, or skipping meals. Check your ketone levels as directed by your doctor, and seek medical attention if you have questions or concerns.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections and kidney problems have been reported with this medication, and may require hospitalization or dialysis.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Birth Control
Women of childbearing age who have not been ovulating may be at risk of pregnancy while taking this medication. If you wish to avoid pregnancy, use birth control while taking this medication. If you become pregnant or suspect you may be pregnant, contact your doctor immediately, as this medication may harm the unborn baby.
Overdose Information
Overdose Symptoms:
- Lactic acidosis (severe metabolic acidosis, hypothermia, hypotension, resistant bradyarrhythmias)
- Hypoglycemia (if co-administered with insulin or sulfonylureas)
- Volume depletion
What to Do:
In case of suspected overdose, contact a poison control center (call 1-800-222-1222) or emergency medical services immediately. Treatment is symptomatic and supportive. Hemodialysis can be useful for removing metformin. Ertugliflozin is minimally dialyzable.
Drug Interactions
Contraindicated Interactions
- Iodinated contrast agents (for metformin, temporarily discontinue before or at the time of the procedure in patients with eGFR between 30 and 60 mL/min/1.73 m2, in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the procedure; restart only if renal function is stable.)
- Patients with eGFR <30 mL/min/1.73m²
Major Interactions
- Alcohol (increased risk of lactic acidosis with metformin)
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide - increased risk of lactic acidosis with metformin)
- Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, isavuconazole, trimethoprim, vandetanib - increased metformin levels and risk of lactic acidosis)
- Loop diuretics (e.g., furosemide - may increase risk of lactic acidosis with metformin due to potential for renal impairment/dehydration)
- Insulin and insulin secretagogues (e.g., sulfonylureas - increased risk of hypoglycemia)
Moderate Interactions
- ACE inhibitors, ARBs, NSAIDs (may impair renal function, increasing risk of metformin accumulation and lactic acidosis)
- Thiazide diuretics (may increase blood glucose, requiring dose adjustment of antidiabetic agents)
- Corticosteroids, sympathomimetics, thyroid hormones (may increase blood glucose, requiring dose adjustment of antidiabetic agents)
- Digoxin (Ertugliflozin may slightly increase digoxin AUC and Cmax, monitor digoxin levels)
- Lithium (SGLT2 inhibitors may decrease lithium levels, monitor lithium levels)
Minor Interactions
- None specifically noted as minor for this combination, but general caution with drugs affecting glucose levels.
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess eligibility for treatment and establish baseline for monitoring due to renal excretion of both components and risk of lactic acidosis with metformin.
Timing: Prior to initiation of therapy.
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function, as severe hepatic impairment is a contraindication for metformin.
Timing: Prior to initiation of therapy.
Vitamin B12 levels
Rationale: Metformin can decrease vitamin B12 levels.
Timing: Prior to initiation of therapy, especially in patients with risk factors for B12 deficiency.
Routine Monitoring
Renal function (eGFR)
Frequency: At least annually; more frequently (e.g., 2-4 times per year) in patients with eGFR <60 mL/min/1.73m² or elderly patients.
Target: >45 mL/min/1.73m² for continued use; >60 mL/min/1.73m² for initiation.
Action Threshold: Discontinue if eGFR persistently falls below 45 mL/min/1.73m². Contraindicated if eGFR <30 mL/min/1.73m².
HbA1c
Frequency: Every 3-6 months.
Target: Individualized, typically <7% for most adults.
Action Threshold: If target not met, consider dose titration or additional therapy.
Blood glucose (fasting and postprandial)
Frequency: Daily self-monitoring as needed, or as directed by healthcare provider.
Target: Individualized.
Action Threshold: Persistent hyperglycemia or hypoglycemia.
Signs/symptoms of lactic acidosis
Frequency: Continuously educate patient.
Target: N/A
Action Threshold: Any suspicion of lactic acidosis (e.g., malaise, myalgia, respiratory distress, somnolence, abdominal distress) requires immediate medical attention and discontinuation of drug.
Signs/symptoms of volume depletion
Frequency: Continuously educate patient.
Target: N/A
Action Threshold: Dizziness, lightheadedness, orthostatic hypotension.
Signs/symptoms of genitourinary infections
Frequency: Continuously educate patient.
Target: N/A
Action Threshold: Dysuria, frequent urination, urgency, vaginal itching/discharge, penile redness/swelling.
Vitamin B12 levels
Frequency: Periodically (e.g., every 1-2 years) in patients on long-term metformin therapy, especially those with risk factors for deficiency.
Target: Normal range.
Action Threshold: If low, consider supplementation.
Symptom Monitoring
- Symptoms of lactic acidosis (unusual muscle pain, trouble breathing, unusual sleepiness, stomach pain, dizziness, lightheadedness, slow or irregular heartbeat)
- Symptoms of hypoglycemia (if used with insulin or sulfonylureas: sweating, trembling, dizziness, confusion, hunger, rapid heartbeat)
- Symptoms of dehydration/volume depletion (dizziness, lightheadedness, orthostatic hypotension)
- Symptoms of urinary tract infection (burning sensation when urinating, frequent urination, urgency, pain in the lower abdomen)
- Symptoms of genital mycotic infection (itching, redness, swelling, discharge in the genital area)
- Symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, excessive thirst, rapid deep breathing, unusual sleepiness, fruity breath odor)
Special Patient Groups
Pregnancy
Use during pregnancy is not recommended, especially during the second and third trimesters. Data on ertugliflozin use in pregnant women are insufficient to determine drug-associated risk. Metformin has been widely studied and is often continued during pregnancy for gestational diabetes or pre-existing type 2 diabetes, but the combination with ertugliflozin is generally avoided due to potential adverse renal effects of SGLT2 inhibitors in the second and third trimesters.
Trimester-Specific Risks:
First Trimester:
Limited human data for ertugliflozin. Metformin generally considered low risk.
Second Trimester:
Ertugliflozin: Not recommended due to potential for adverse renal effects in the developing fetus (dilated renal pelvis, hydronephrosis) based on animal data.
Third Trimester:
Ertugliflozin: Not recommended due to potential for adverse renal effects in the developing fetus (dilated renal pelvis, hydronephrosis) based on animal data.
Lactation
Not recommended during breastfeeding. Ertugliflozin is present in the milk of lactating rats, and it is unknown if it is present in human milk. Metformin is excreted into human milk in small amounts and is generally considered compatible with breastfeeding by many experts, but the combination product is not recommended due to the ertugliflozin component.
Infant Risk:
Ertugliflozin: Potential for serious adverse reactions in a breastfed infant (e.g., renal dysfunction, dehydration). Metformin: Low risk, generally considered safe.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients (<18 years of age). Not recommended for use in this population.
Geriatric Use
No dose adjustment is recommended based on age alone. However, older patients are more likely to have decreased renal function, and renal function should be assessed more frequently. They may also be at higher risk for volume depletion and lactic acidosis. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Segluromet combines an SGLT2 inhibitor (ertugliflozin) and a biguanide (metformin), offering complementary mechanisms of action for glycemic control in type 2 diabetes.
- Renal function is a critical consideration for Segluromet. It is contraindicated in patients with eGFR <30 mL/min/1.73m² and not recommended to initiate if eGFR <45 mL/min/1.73m².
- Patients should be educated on the signs and symptoms of lactic acidosis (a rare but serious side effect of metformin) and instructed to seek immediate medical attention if they occur.
- Due to the SGLT2 component, patients are at increased risk for genitourinary mycotic infections and volume depletion. Adequate hydration is important.
- Temporarily discontinue Segluromet before or at the time of iodinated contrast imaging procedures in patients with certain risk factors for acute kidney injury.
- Monitor for signs of diabetic ketoacidosis, even with normal or mildly elevated glucose levels (euglycemic DKA), especially in patients with risk factors such as acute illness, reduced caloric intake, or reduced insulin dose.
Alternative Therapies
- Other oral antidiabetic agents (e.g., sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, TZDs)
- Insulin therapy
- Lifestyle modifications (diet and exercise)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$600 per 30 tablets
Insurance Coverage:
Tier 2 or 3 (Preferred or Non-Preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.